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Obturator and Femoral Nerve Block in Patients With Hip Fracture

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical suspicion of hip fracture
  • Age ≥ 55 years
  • Mentally capable of comprehending and using verbal pain score
  • Mentally capable of differentiating between pain from the fractured hip and pain from other locations
  • Mentally capable of understanding the given information
  • Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
  • Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
  • Patients informed consent

Exclusion Criteria:

  • Hip fracture not confirmed by x-ray
  • Weight < 40 kg
  • Patient has previously been included in this trial
  • If the patient wishes to be excluded
  • Allergy to local anesthetics or adrenocortical hormone
  • Visible infection in the area of the point of needle injection

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivacaine

Saline

Arm Description

Obturator nerve block

Saline is injected as a placebo

Outcomes

Primary Outcome Measures

Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Success rate of successful analgesia compared between the groups

Secondary Outcome Measures

Median pain score (NRS 0-10)
Median pain score 30 minutes after the nerve blocks compared between the groups
Median change in pain score (NRS 0-10)
Median change in pain score 30 minutes after the nerve blocks compared between the groups
Course in pain reduction
Course in pain reduction during the 30 minutes after the nerve blocks
Time to sufficient analgesia
Time from ended injection until sufficient analgesia
Frequency of anesthesia in the skin area of the saphenous nerve
Frequency of anesthesia in the skin area innervated by the saphenous nerve
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Localization of the worst pain before block
Localization of the worst pain before any nerve blocks
Localization of the worst pain after block
Localization of the worst pain 30 minutes after the nerve blocks
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Discomfort during the nerve block procedures compared between procedures
Satisfaction (0-10, 0= very unsatisfactory)
Patient satisfaction with the pain treatment
Frequency of ultrasound visualization of femoral nerve
Frequency of patients with possible ultrasound visualization af the femoral nerve
Frequency of ultrasound visualization of obturator injection site
Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
Time spend on femoral nerve block
Time spend on conducting the femoral nerve block
Time spend on obturator nerve block
Time spend on conducting the obturator nerve block
Total morphine equivalent dose of opioid from the time of nerve block to operation
Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block

Full Information

First Posted
August 27, 2015
Last Updated
May 13, 2016
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02540837
Brief Title
Obturator and Femoral Nerve Block in Patients With Hip Fracture
Official Title
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve. The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Detailed Description
A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown. With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done. The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Obturator nerve block
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline is injected as a placebo
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Active nerve block
Intervention Description
Obturator nerve block
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
Obturator nerve block with saline(placebo)
Primary Outcome Measure Information:
Title
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Description
Success rate of successful analgesia compared between the groups
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Median pain score (NRS 0-10)
Description
Median pain score 30 minutes after the nerve blocks compared between the groups
Time Frame
30 minutes
Title
Median change in pain score (NRS 0-10)
Description
Median change in pain score 30 minutes after the nerve blocks compared between the groups
Time Frame
30 minutes
Title
Course in pain reduction
Description
Course in pain reduction during the 30 minutes after the nerve blocks
Time Frame
30 minutes
Title
Time to sufficient analgesia
Description
Time from ended injection until sufficient analgesia
Time Frame
30 minutes
Title
Frequency of anesthesia in the skin area of the saphenous nerve
Description
Frequency of anesthesia in the skin area innervated by the saphenous nerve
Time Frame
30 minutes
Title
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Description
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Time Frame
30 minutes
Title
Localization of the worst pain before block
Description
Localization of the worst pain before any nerve blocks
Time Frame
0 minutes
Title
Localization of the worst pain after block
Description
Localization of the worst pain 30 minutes after the nerve blocks
Time Frame
30 minutes
Title
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Description
Discomfort during the nerve block procedures compared between procedures
Time Frame
5 minutes
Title
Satisfaction (0-10, 0= very unsatisfactory)
Description
Patient satisfaction with the pain treatment
Time Frame
30 minutes
Title
Frequency of ultrasound visualization of femoral nerve
Description
Frequency of patients with possible ultrasound visualization af the femoral nerve
Time Frame
5 minutes
Title
Frequency of ultrasound visualization of obturator injection site
Description
Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
Time Frame
5 minutes
Title
Time spend on femoral nerve block
Description
Time spend on conducting the femoral nerve block
Time Frame
5 minutes
Title
Time spend on obturator nerve block
Description
Time spend on conducting the obturator nerve block
Time Frame
5 minutes
Title
Total morphine equivalent dose of opioid from the time of nerve block to operation
Description
Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
Time Frame
Approximately 24 hours in average
Title
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Description
Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
Time Frame
Approximately 24 hours in average
Title
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Description
Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
Time Frame
10 hours
Title
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Description
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical suspicion of hip fracture Age ≥ 55 years Mentally capable of comprehending and using verbal pain score Mentally capable of differentiating between pain from the fractured hip and pain from other locations Mentally capable of understanding the given information Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest Patients informed consent Exclusion Criteria: Hip fracture not confirmed by x-ray Weight < 40 kg Patient has previously been included in this trial If the patient wishes to be excluded Allergy to local anesthetics or adrenocortical hormone Visible infection in the area of the point of needle injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas D. Nielsen, M.D.
Phone
+45 28782877
Email
thomas.dahl.nielsen@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas F. Bendtsen, Ph.d.
Phone
+45 51542997
Email
tfb@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F. Bendtsen, Ph.d.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas D. Nielsen, MD
Phone
+45 28782877
Email
thomas.dahl.nielsen@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Thomas F. Bendtsen, MD, Ph.d.
Phone
+45 51542997
Email
tfb@dadlnet.dk

12. IPD Sharing Statement

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Obturator and Femoral Nerve Block in Patients With Hip Fracture

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